This was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule \[LFC\]) in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
26
Clinical Trial Site
Auckland, New Zealand
PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations
Time frame: Up to 96 hours postdose
PK: Time To Reach The Maximum Plasma Concentration (Tmax) Of Danicopan After Treatment With Each Of The Three Formulations
Time frame: Up to 96 hours postdose
PK: Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-Inf) Of Danicopan After Treatment With Each Of The Three Formulations
Time frame: Up to 96 hours postdose
PK: Cmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Time frame: Up to 96 hours postdose
PK: Tmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Time frame: Up to 96 hours postdose
PK: AUC0-inf Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Time frame: Up to 96 hours postdose
Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), And AEs Leading To Discontinuation
Time frame: Day 1 through Day 39
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